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Study Management

PRE STUDY

Protocol Template: A protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a trial. The ICH Good Clinical Practice Guidelines specify some topics that should generally be included in a protocol. There are several templates that help you develop a protocol. Click here for a simple protocol template.

Many of the NIH institutes have their own protocol templates. There are several example templates in the NIAID website.

Budget Development: Budget development involves three components:

identifying the cost of all research items and services required for the study

assigning financial responsibility for all items and services; and

maintaining a process for recovering costs throughout the study.

Every investigator should have a clear financial management plan to adequately support their research endeavors. The plan should include a defined department process and a responsibility log which outlines the team members accountable for the process. The CTRC offers many training opportunities, one-on-one consultations, tools, policies, and guidance documents to support researchers and their team in sound budget development. See this pagefor more information and templates, and also the Financial Management Worksheet.Feasibility Checklist: When approached with an invitation to participate in a clinical trial, the investigator usually receives a copy of the protocol or a protocol synopsis. It is very important to carefully review and evaluate the protocol and determine if appropriate patient population and resources are available for successfully completing the trial. The feasibility checklist gives you a list of questions that you should consider before agreeing to participate in a trial. Click here for a sample of the feasibility checklist.

STUDY INITIATION

Regulatory Binder: The regulatory binder contains all the important study documents. Essential Documents are those documents which individually and collectively permit the evaluation of the conduct of the trail and the quality of the data produced. Filing these documents in a timely manner can greatly assist in the successful management of a trial. Click here for a list of documents that need to be maintained in a Regulatory Binder.

Study Responsibility Log: Conducting a clinical trial is clearly a team effort with every member in the study team playing an important role. However, the overall responsibility for a clinical trial rests with the Principal Investigator. The Principal Investigator then delegates specific responsibilities to various members within the team. These responsibilities should be formally assigned. The Study Responsibility Log helps keep track of the responsibilities of the various team members. Click here for a sample Study Responsibility Log.

Study Worksheet: For some studies creating simple reminders or worksheets will help staff obtain the required data in a timely fashion and greatly helps in reducing the number of missing data points. Worksheets can serve as a reminder to ensure that all protocol specific procedures are completed in a timely manner. Click here for a sample of a Study Worksheet.

Schedule of Assessments: The protocol should clearly outline the activities that are to be performed for the research study. This includes a plan for administration of study treatment and a list of assessments and procedures that are to be performed for the duration of the study.

SUBJECT MANAGEMENT

Master Subject Log: Most clinical trials involve multiple study visits over an extended period of time. While it is very important to maintain subject privacy and confidentiality, a study coordinator's job also involves making sure that subjects come for their follow up visits on schedule. A study coordinators job is made much easier to have all the subject contact information in one place. In conjunction with the Subject Visit Schedule log, this log will help make the study coordinators job a bit easier. Click here for a sample Master Subject Log.

Subject Screening and Enrollment Log: Usually a research team has to screen several subjects to find subjects who are eligible for participation in a particular study. No subject may be screened without informed consent, unless this was waived by an IRB. It is important to keep track of all the subjects who agreed to participate in a research study by signing the informed consent form. Some of these subjects may be screen failures, some may withdraw after a few visits while others go on to complete the study. This log helps keep track of study subjects. Click here for a sample of a Subject Screening and Enrollment Log. Subject Visit Schedule Log: Most coordinators work on several studies simultaneously. It is very difficult to keep track of subject visits especially when studies involve multiple visits over long periods of time. This Subject Visit Schedule log will help you keep track of subject visits and will also help you calculate subsequent visits. Click here for a sample of Subject Visit Schedule Log.

TRACKING AND REPORTING

Adverse Event Tracking Log: At every study visit, the subject should be observed for adverse events and should be asked about any adverse event that might have happened since the previous visit. Most of these adverse events might not meet the definition of an Unanticipated Problem Involving Risks to Subjects or Others. However, all these events need to be tracked meticulously. Click here for a sample of an Adverse Event Tracking Log. Protocol Deviation Log: It is important to follow the protocol very strictly, however, sometimes deviations do occur due to various reasons. Some protocol deviations might meet the definition of an Unanticipated Problem Involving Risks to Subjects or Others. This log will help keep track of all the protocol deviations and will serve as a documentation of the determination of whether a particular deviation should be submitted to the IRB or not. Click here for a sample of a Protocol Deviation Log.

ACCOUNTABILITY LOGS

Device Accountability Log: Investigators are responsible for maintaining strict control over investigational devices to ensure that the device is used only for subjects enrolled in the study. This log helps maintain an inventory of the study device. Click here for a sample of a Device Accountability Log. Drug Accountability Log: Investigators are responsible for maintaining strict control over investigational drugs to ensure that the device is used only for subjects enrolled in the study. This log helps maintain an inventory of the study device. Click here for a sample of a Drug Accountability Log.Specimen Log: Safety laboratory assessments are usually part of most clinical trials that involve an investigational test article. Biological materials might be sent to the local laboratory or to a central laboratory. In any case, it is important to keep track of the samples that are collected from study subjects. Click here for a sample of a Specimen Log.

QUALITY MANAGEMENT

Quality Management Plan: Ideally, every study should have a monitoring plan as part of the quality management plan. Quality Management Plans include all the activities undertaken to verify that the requirements for quality of the trial related activities have been fulfilled. Some of the logs and checklists that might help with the quality management plan are (see also this page):